Dobbhoff Polypectomy Snare

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Dobbhoff(R) Polypectomy Snare

510(k) Number

K901322 ↗

FDA Product Code

FDI

Device Class

Class II

Regulation

21 CFR Part 876.4300

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Entron Enteral Feeding Bag

  Class II

  FDA 510(k) K850134 Active Cleared 14 Feb 1985

• Peewee Replacement Gastrostomy Tube

  Class II

  FDA 510(k) K903662 Active Cleared 12 Dec 1990

• Islami Gastrointestinal Tube

  Class II

  FDA 510(k) K834268 Active Cleared 4 Feb 1984

• Pedi-Tube Pediatric Feeding Tube

  Class II

  FDA 510(k) K822875 Active Cleared 13 Oct 1982

• Enteral Feeding Tube

  Class II

  FDA 510(k) K051480 Active Cleared 12 Oct 2005

• Ambi-24 Ph/Pressure Monitor

  Class I

  FDA 510(k) K854514 Active Cleared 24 Feb 1986

See all devices from Biosearch Medical Products, Inc. →

• Is the Dobbhoff Polypectomy Snare intended for use in both colon and upper gastrointestinal procedures, and how does its design support this flexibility?

  Yes, the Dobbhoff Polypectomy Snare is designed for use in both the colon and upper gastrointestinal tract. Its flexible construction allows for precise manipulation within these areas, enabling safe and effective excision of polyps during endoscopic procedures. The snare’s adaptability is key to navigating the varying anatomies of these regions.

• What is the intended use of the Dobbhoff Polypectomy Snare, and which medical specialties commonly utilize this device?

  The Dobbhoff Polypectomy Snare is intended for the removal of polyps—both benign and malignant—during endoscopic procedures. It is primarily used in Gastroenterology and Urology settings, where precise polypectomy is required. The device’s classification under FDA regulation 876.4300 (Snare, Flexible) reflects its role in these specialties.

• Is the Dobbhoff Polypectomy Snare sterile when supplied, and how should it be handled before use?

  The Dobbhoff Polypectomy Snare is supplied as a single-use, non-sterile instrument. Before use, it must be sterilized according to standard medical protocols to ensure patient safety. Always follow facility-specific guidelines for sterilization and preparation.

• What regulatory pathway was followed for the FDA clearance of the Dobbhoff Polypectomy Snare, and what does the 'Substantially Equivalent' determination mean?

  The Dobbhoff Polypectomy Snare received FDA clearance via a 510(k) submission (K901322) under the Traditional Review pathway, with a Substantially Equivalent (SESE) determination. This means the device was found to be as safe and effective as a legally marketed predicate device already on the market, meeting FDA standards for flexible snares used in polypectomy.